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Effects of Dietary Inorganic Nitrate Supplementation on Exercise Performance in Heart Failure

Effects of Dietary Inorganic Nitrate Supplementation on Exercise Performance in Heart Failure

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000906550
Enrollment
28
Registered
2015-09-01
Start date
2016-04-26
Completion date
2018-06-13
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project will investigate if 7 days of dietary inorganic nitrate supplementation (beetroot juice) versus placebo in a randomized, double blind, cross-over design, can improve exercise tolerance in heart failure (HF) patients with preserved ejection fraction (HFpEF, n=15) and with reduced ejection fraction (HFrEF, n=15). The testing protocols are designed to investigate the oxygen consumption system at multiple levels that may mediate exercise performance. These include assessments during exercise of gas exchange, cardiac function, VO2kinetics, skeletal tissue oxygen extraction and nitric oxide metabolism. Additional resting measures of vascular function and stiffness, tissue perfusion and mitochondrial function (biopsy) will be performed. The hypothesis of this proposal is that in subjects with HFpEF and HFrEF, regular consumption of beetroot juice for 7-10 days will produce a clinical benefit in exercise tolerance (increase in VO2peak and time to exhaustion) versus a placebo.

Interventions

All participants will consume 210mL of inorganic beetroot juice per day: -Two 70mL bottles of inorganic beetroot juice -One 70mL bottle of sport inorganic beetroot juice) Beetroot juice is sourced from :BEET IT shot, James White Drinks, Ipswich, UK Participants will consume the the sport shot in the morning, and one of each of the other two bottles midday and at night. The sport shot contains approximately 6.4mmol of nitrate and each organic shot contains approximately 4.8mmol of nitrate per

All participants will consume 210mL of inorganic beetroot juice per day: -Two 70mL bottles of inorganic beetroot juice -One 70mL bottle of sport inorganic beetroot juice) Beetroot juice is sourced from :BEET IT shot, James White Drinks, Ipswich, UK Participants will consume the the sport shot in the morning, and one of each of the other two bottles midday and at night. The sport shot contains approximately 6.4mmol of nitrate and each organic shot contains approximately 4.8mmol of nitrate per bottle, with a total daily dosing of 16mmol nitrate. Participants will be required to have at least 7 days of supplementation with the beetroot juice, but depending on subject availability, the total days dosing could vary between subjects. One subject might have availability to complete all round 1 testing visits within a week, whereas another subject could require a week and a half to complete all visits. Previous research does not indicate any further benefits of nitrate dosing beyond 6 days, so we do not expect the total days dosing to affect the study outcome providing all subjects meet the minimum of 7 days supplementation. Following supplementation, subjects will undergo a minimum of two week wash-out period. Adherence will be managed by reminder phone calls to subjects during the supplementation period. They will also be asked to keep a record of when they consumed the supplement. and return the empty bottles to the research team.

Sponsors

Jason Allen
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

Recruitment will be for individuals between the ages of 18 and 85 who have diagnosed stable Heart Failure ((HF) with either reduced ejection fraction of less than or equal to 40 percent (HFrEF) or preserved ejection fraction of greater than or equal to 50 percent (HFpEF) andno major changes in medications for at least 3 months. Additional inclusion criteria include: NYHA class II-III HF; receiving optimal medical therapy and a peakVO2 between 10 and 30 ml/kg/min. Furthermore HFpEF inclusion criteria includes: evidence of diastolic dysfunction via an echocardiography (ECHO) or brain natriuretic peptide (BNP).

Exclusion criteria

A major cardiovascular event or procedure within the previous 6 weeks or plans for hospitalisation or cardiac transplantation within the next 2 months; foot ulcers/Advanced neuropathy; abnormal responses to cardiopulmonary exercise testing (CPX) as defined by AACVPR or other co-morbidities or limitations that preclude safe participation in the exercise testing; inability to walk on treadmill; Allergy to beets, beet juice, milk or soy; Refusal or inability to abstain from the use of proton pump inhibitors for 24 hours prior to testing visits.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 24, 2026